Less than nine months after naming its first diagnostic partner, Swiss semiconductor company-turned-biochip start up ST Microelectronics said it plans to release a second IVD on its In-Check platform by the end of this year.
The company said last week in a statement that it is now working with Singapore-based Veredus Laboratories to release a rapid biochip-based test panel for influenza that will include strains of influenza H5N1, or bird flu, and allow users to identify strains of the virus in one hour.
ST stated in September 2005 that it is working with Helsinki, Finland-based Mobidiag to release a test for sepsis identification by the end of 2006 (see BAN 9/21/2005). This project is still ongoing. In both cases, ST has said it is incumbent on the test developer to earn US Food and Drug Administration clearance for the test.
ST's product development manager Rob Hodges told BioArray News this week that Veredus has several tests already developed for influenza, malaria, and other diseases, and that it made sense to migrate the content from those tests, which are gel-based, to a multiplex format.
He also said that ST expects the Veredus test and Mobidiag's sepsis test, called Prove It!, to reward his biochip business with some positive cash flow.
"It depends on if [avian flu] becomes a pandemic or not. We haven't been able to forecast numbers at this point. We are working to be prepared."
"The projects that we have announced are two very value-added applications," Hodges said. "They will be a good first step for us in order to start generating some volume, generating some revenues, and be able to leverage that into other applications." He declined to discuss pricing for the instrumentation.
Though Hodges calls ST's chips "microarrays," the firm's chips are actually microfluidics-based, differing from conventional hybridization-based arrays. However, the company is following in the path of other, older microarray firms like Affymetrix by partnering with diagnostic shops to provide the content for diagnostic assays.
ST has also decided not to enter the tools market, opting instead to let its diagnostic partners distribute the In-Check system -- with its PCR system, scanner, informatics, and thermal controls -- alone. And users will be obliged to buy the whole kit because ST's chips do not work on other platforms, according to Hodges.
"We will be distributing the instrumentation most likely through our partners to their customers," Hodges said. "You can think of it as an inkjet printer and inkjet cartridges. Once you get the printer you consume the cartridges and it's a similar concept with our platform."
A 'Double-Edged Sword'
According to last week's statement, the flu chip will be available by the fall of this year, just in time for flu season.
Still, ST and Veredus may be at a chronological disadvantage, because rival array companies have their own tests for flu, including avian flu, that are either on the market, or may make it onto the market ahead of ST and Veredus.
For example, last month San Diego-based Nanogen released its NGEN RVA analyte specific reagent kit that it claims can be used to develop and validate assays to detect influenza A and B, respiratory syncytial virus, parainfluenza 1, 2, and 3, and the H5N1 strain of the influenza A virus. The product, which was co-developed with Prodesse, has been cleared for sale in Europe, Nanogen said. (see BAN 12/14/2005).
Also in December, CombiMatrix Molecular Diagnostics, a fully owned subsidiary of CombiMatrix, announced plans to introduce a service for flu testing -- its first -- which it claims can identify types of influenza, including the H5N1 bird flu, as well as mutations and novel strains of flu. The test has been available with a research-use-only label since last month, and CMD is hoping to be able to provide clinical results if it receives CLIA approval next month, CMD CEO Matt Watson told BioArray News at the time (see BAN 12/14/2005).
Veredus CEO Rosemary Tan told BioArray News this week that firms like hers are being enticed into the flu chip marketplace by what is seen as "high demand" for a good test that can identify flu strains. She said she lacks an estimate of the size of the market because it has yet to mature.
"Like with all new technologies, it takes time to [get a sense of] the market," Tan said. Similarly, Hodges declined to provide a market estimate.
"Forecasting numbers is extremely difficult and it's a double-edged sword because if the volumes are needed it's a bad sign for humanity," he said. "It depends on if it becomes a pandemic or not. We haven't been able to forecast numbers at this point. We are working to be prepared," Hodges said.
A representative for Nanogen put the approximate size of the market for respiratory virus testing at $100 million, but did not specify the size of the market for flu chips alone.
Tan said that Veredus had chosen to work with ST because it had confidence in the quality of its platform, and that it has plans to release future testing panels for diseases like malaria in the next two years.
Following a model more similar to Nanogen's than CMD's, Hodges said that ST considers its strengths in the marketplace to be the portability and cost of its benchtop instrumentation (although he declined to provide pricing for the system or the Veredus testing panel) and added that the company has a clear idea of where it plans to sell the system upon completion.
"It will be more [geared toward] distributive testing, not necessarily just for reference labs," Hodges explained. Prospective clients may include clinics, hospitals, as well as selling to health ministries and port authorities for testing at point of entry, he said.
— Justin Petrone ([email protected])